Generation of a specific polyclonal antibody with high affinity to atorvastatin and its employment in the development of ELISA for determination of atorvastatin in plasma.

For the first time, a polyclonal antibody with high affinity to atorvastatin (ATR) was generated. The high specificity of the antibody for ATR among its structural analogues and co-administered therapeutic agents was proved. The antibody was employed in the development of enzyme-linked immunosorbent assay for quantitation of ATR in plasma. The assay was validated over a working range of 0.2-5 ng/mL. The intra- and interassay precisions were satisfactory; the coefficients of variations were ≤5%. The accuracy of the method was proved as the mean recovery was 96.4 ± 4.3%. The assay can be used in therapeutic monitoring and pharmacokinetic studies for ATR.